ABL90 FLEX PLUS Instructions for Use Sw Ver 3.5 Sept 2020

Contents 1.

Introduction Intended use ... 1

Limitations of use... 2 About limitations of use...2 Measurement of FHbF... 2 Operator training requirements... 2 About this document... 2 Documentation...3 About hazards...3 General warning and cautions... 3 Reference... 3

2.

Getting to know the analyzer Overview of the analyzer... 5 Front view... 5 Side and back view... 6 Consumables... 7 To see details about installed consumables...8

Is the analyzer ready for use?... 8 Three important conditions... 8 Parameter tab colors...8 To access the Analyzer status screen...9 The Analyzer status screen... 10 Analyzer status - Traffic light colors... 10 Messages...10 To find and troubleshoot messages in the Analyzer status screen... 11 Is the analyzer operating on battery power?... 12

Common tasks... 13 To log on... 13 To get quick access to the start screen...13 To scan a barcode... 13 To enter text... 13 To select/deselect a check button...13 To save changes... 14

Menu... 15 Menu structure... 15

Data logs... 16 About data logs... 16 Overview of data logs...16 To access data logs... 16

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ABL90 FLEX PLUS: Instructions for use

Patient sample analysis General warnings and cautions... 17 Anticoagulants... 17

Good results come from good samples... 18 What is a good sample?...18 To get a good sample... 18 To mix a sample on the analyzer... 19 Storage recommendations... 19

Pre-registration of samples... 20 About sample pre-registration... 20 To pre-register a sample... 21

Analyzing patient samples... 21 General information for obtaining successful patient sample analyses... 21 To analyze a sample from a syringe...22 To analyze a sample from a capillary tube... 23 To analyze a sample from a test tube... 25 To get calculated values for FShunt and ctO2(a-v)̄ ... 26

Entering and editing data in the Patient identification screen... 27 The Patient identification screen...27 To change the report layout in the Patient identification screen... 27 To request patient data automatically when connected to a LIS/HIS system...27 To request patient data using Patient lookup...28 To edit data in the Patient identification screen... 28

Patient results... 28 To find a patient result...28 Symbols on patient results... 28 About ranges and critical limits... 29 Status in the Patient results log... 30 To see messages on patient results... 30 To troubleshoot messages on results... 30 To see the acid-base chart for a result... 30

Reviewing and editing patient results... 30 To filter data from the Patient results log...30 To see trends in a patient's results... 31 To see the audit trail on a patient result... 31 To add a note to a patient result ... 31 To remove a parameter from a patient result... 32 To show a parameter in a patient result... 32 Approval and rejection of patient results... 32 To approve a patient result...32 To reject a patient result... 33

Critical limit notification... 33 About Critical limit notification... 33 To enable Critical limit notification... 33 To use Critical limit notification... 33 Pending results log...34 To access the Pending results log... 34 Input fields for the Patient report layout...34 References...34

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Replacements and maintenance General warnings and cautions... 37 To order products for use with your analyzer... 37 Replacement intervals for consumables and Inlet Connector Gasket...37

Replacements... 38 Solution Pack... 38 To see the Solution Pack status...38 To replace the Solution Pack... 38 Can a Solution Pack be used again?...40 Status logs... 40 To print Solution Pack status logs... 40 To export Solution Pack status logs... 40

Sensor Cassette... 41 To see the Sensor Cassette status... 41 To replace the Sensor Cassette... 41 Calibration frequency after a Sensor Cassette SC90 replacement ...42 Can a Sensor Cassette be used again?...42 Status logs... 42 To print Sensor Cassette status logs... 42 To export Sensor Cassette status logs...42

Thermal printer paper... 43 To replace the thermal printer paper...43 Protection of printed data... 43

Inlet Module... 44 To replace the Inlet Module... 44

Inlet Gasket Holder... 45 To replace the Inlet Gasket Holder...45

Inlet Probe... 47 To replace the Inlet Probe... 47

Inlet Connector Gasket... 49 To replace the Inlet Connector Gasket... 49

Maintenance... 51 Cleaning... 51 Cleaning - when is it necessary?... 51 To clean the inlet gasket... 51 To clean the touch screen... 52 To clean the analyzer exterior...52 To clean the QUALICHECK Opener/Adapter...52

Disinfecting... 53 Disinfection - when is it necessary?... 53 To disinfect the touch screen ... 53 To disinfect the analyzer exterior... 54 To disinfect the fluid transport system... 54

Battery... 54 To recharge the analyzer battery...54 To install and service the battery...54

Disposal... 55 To dispose of the analyzer...55

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Connecting peripherals... 55 To connect a USB external keyboard / mouse... 55 To connect a non-USB (PS/2) external keyboard or mouse... 55 To connect an external barcode reader...55 To connect the analyzer to a network...56 Reference... 56

5.

Quality control Overview of quality control management... 57 To find the status of QC measurements...57 Symbols that show the status of QCs...57

Automatic quality control management... 57 About automatic quality control management... 57 About system checks...58 Overview of automatic quality management... 58

Built-in QC... 59 About built-in QC measurements...59 Built-in QC measurement frequency... 59 To request an unscheduled built-in QC measurement... 60

Built-in QC results... 60 Status of built-in QC measurements... 60 To find a built-in QC result... 60 Symbols on built-in QC results...60 To see messages on built-in QC results... 61 To troubleshoot messages on built-in QC results...61

Quality control management done by operators... 61 Quality control management that can be done by operators...61

Ampoule-based QC measurements... 62 QC solutions for ampoule-based measurements... 62 How to get good ampoule-based QC measurement results... 62 To prepare a Radiometer QC ampoule for use... 63 To do a Radiometer ampoule-based QC measurement from the Analyzer status screen...64 To do an ampoule-based QC measurement from the start screen... 66 To edit QC identification data...68

Ampoule-based QC results... 68 Status of ampoule-based QC measurements...68 To find an ampoule-based QC result... 68 Symbols on ampoule-based QC results... 68 To see messages on ampoule-based QC results...69 To troubleshoot messages on results... 69

Calibration verification...69 About calibration verification... 69 Frequency of calibration verification... 69

Stage 1 - Analyzing different levels of control solution... 70 To prepare a Radiometer calibration-verification ampoule for use...70 To do a calibration-verification measurement... 71

Stage 2 - Using results to verify reportable ranges... 72 To find a calibration-verification measurement result... 72 Symbols on calibration-verification measurement results...73

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To temperature correct calibration-verification results based on Range+ QUALICHECK measurements... 73 To use temperature-corrected calibration-verification results...74

Stage 3 - Changing reportable ranges... 74 To change the reportable range of parameters... 74

Reviewing QC statistics... 75 To find and print QC statistics... 75 QC plots... 75 To find a QC plot...76 To filter data from the Quality control log... 76 To see trends in QC results...77

WDC file export...77 About WDC... 77 To export WDC files...77

Analyzing QC solutions in other modes... 77 About analyzing QC solutions in other modes...77 To temperature correct results based on QUALICHECK5+ solutions... 78

6.

Calibration Overview of calibrations...79 Frequency of automatic calibrations...79 To find the status of calibrations... 80 Symbols that show the calibration status... 80

Automatic calibrations...80 To request an unscheduled calibration from the Analyzer status screen... 80 To request an unscheduled calibration from the menu... 81

Manual tHb calibrations... 81 To do a tHb calibration...81

Calibration results... 83 To find a calibration result... 83 Identification of calibrations in the Calibration log screen...83 Understanding calibration results... 83 To see messages on a calibration result... 84 To troubleshoot messages on results... 84

Reviewing calibration results... 84 To filter data from the Calibration log...84 To see trends in calibration results... 84 Status in the Calibration log screen... 85

7.

Troubleshooting Troubleshooting - when is it necessary?... 87 About guided troubleshooting... 87 To get out of Operator Action Needed mode...87 To get out of Troubleshooting needed mode...87 To get out of Intervention Required mode... 87 Troubleshooting modes - causes... 87 To find and troubleshoot messages in the Analyzer status screen... 88 To flush the fluid transport system... 89

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Operator actions requested in analyzer messages... 92 To request a tubing refill... 92 To request a liquid sensor adjustment...92 To request a pump calibration...92 To request a rinse... 92 Automatic and manual flush ... 92 To request an automatic flush of the analyzer ... 92 To perform a manual flush of the analyzer ...92

Troubleshooting Analyzer messages... 93 To troubleshoot Analyzer messages... 93 Analyzer messages... 93

Activity log... 129 About the Activity log... 129 To troubleshoot messages in the Activity log... 130 To see activities in the Activity log... 130 To add a message to the Activity log...130 To filter activities from the Activity log... 130

Analyzer service... 130 For service... 130 To find the installation number (serial number) of the analyzer...130 To find the version of software installed...131

8.

Shutting down, moving and restarting the analyzer Shutdown... 133

Temporary shutdown of the analyzer... 133 When to do a temporary shutdown... 133 To do a temporary shutdown... 133

Long-term shutdown of the analyzer... 133 When to do a long-term shutdown...133 To do a long-term shutdown ... 134

Storing the analyzer...135 To store the analyzer... 135

Moving the analyzer... 136 To move an analyzer that has a charged battery...136 To move an analyzer that does not have a battery... 136

Restarting the analyzer... 136 To restart the analyzer after a temporary shutdown... 136 To restart the analyzer after a long-term shutdown...136

9.

Setup Setup menu structure...139 To print setups...140

Managing operators... 140 To select the logon procedure... 140 Access profiles...140 To edit an access profile... 140 Anonymous use... 141 To set up anonymous use...141 Default operators... 141

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To add an operator... 141 To remove an operator...142 To set a logoff time for all operators... 143 Centralized user management...143 To set up centralized user management... 143

Managing patient profiles... 144 Patient profiles log... 144 To see the data saved in a patient profile...144 To find a patient profile... 144 To edit a patient profile... 144 To add a new patient profile... 144 To delete a patient profile...144

Analyzer operations... 145 To lock the analyzer... 145 To unlock the analyzer... 145 To lock/unlock parameters for measurement...145 To show a message on the analyzer screen...145

Sample counter... 146 To see an overview of measurements and tests done on the analyzer...146 Sample counter... 146 To reset the counters in the User column...146

Analyzer settings... 146 To set up corrective actions on system messages... 146 To enable data to be scanned from barcodes...147 To create a heading for printed data... 147 To enable the screen saver... 147 To set the time and date... 147 To set the acoustic signals... 148 To mute all acoustic signals... 148 To change the screen language... 148 To select a regional setting... 148 To set the barometric pressure...149 To log all measurement activities...149

Analysis setup... 149 Analysis modes... 149 Syringe modes... 149 To edit a syringe mode...150 To create a new syringe mode...150 To remove a measurement mode... 151 To select a default measurement mode... 151 To select a specific patient report layout for an analysis mode... 151 To set up a calibration-verification mode... 152 To set up an ampoule QC mode...152 Capillary modes... 152 To edit a capillary mode... 153

Ranges and critical limits... 153 About ranges and critical limits... 153 About reference ranges...154 Reference range of measured parameters...154 About critical limits...154 To set the limits for patient age groups... 155 To set up reference ranges and critical limits...155

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About reportable ranges...155 To set up reportable ranges... 156 About range of indication... 156

Sample pre-registration... 156 About sample pre-registration...156 To set up sample pre-registration... 156

Sample age evaluation... 157 About sample age evaluation... 157 Maximum sample age...157 To set a maximum sample age...157 Max sample age...157

Patient report layouts... 158 About patient report layouts... 158 To create a patient report layout... 158 To change a patient result layout...159 To create extra items for use in patient report layouts... 160 To select a patient report layout as default... 161 To automatically change the temperature units... 161 To edit a patient report layout...161 To create a patient report layout for FShunt and ctO2(a-v̄)... 162

Patient result settings... 163 To set up automatic printing of acid-base charts... 163 Approval and rejection of patient results... 163 To enable patient result approval/rejection... 163

Parameter settings... 163 To show the parameter bar...163 To hide the parameter bar... 164 To enable/disable a parameter... 164 To set up measuring units for parameters...164 To repress a parameter... 164 To suppress out-of-range results... 164 To fix the number of decimals used in blood-gas results... 165 To enable HbF corrections... 165 To enable the estimation of derived parameters... 166

Editing the slope and offset of a parameter... 166 Operator-defined corrections (offset and slope)... 166 Recommendations about samples to use... 167 Limits for slope and offset values... 168 To edit the offset and slope for a parameter...169

Calibration settings... 169 Details about calibration frequency... 169 To edit the calibration schedule... 170 To link the built-in QC schedule to the calibration schedule... 171 To set up corrective actions for overdue scheduled calibrations...172

Quality control... 172 Glossary of quality control terms... 172

Registration of QC solutions... 173 Why is it necessary to register QC solutions?... 173 About registration of QC solutions... 173 To register a Radiometer QC solution for ampoule-based QC measurements...173 Data saved during registration of Radiometer QC solutions... 173

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To register a non-Radiometer QC solution...174 Data saved during registration of non-Radiometer QC solutions... 175

Quality control solutions... 175 To set up the temperature field for QC measurements... 175

Scheduled QC measurements... 176 To schedule ampoule-based QC measurements... 176 To edit the schedule for ampoule-based QC measurements... 176 Built-in QC measurement frequency... 177 To edit the schedule for built-in QC measurements... 177 To request ampoule-based QC measurements after replacements... 178

Corrective actions on QC results... 179 To set up corrective action for errors in QC results... 179 To set up corrective actions for overdue scheduled QC measurements... 179 To apply operator-defined corrections to QC results... 180 To set up corrective action for errors in built-in QC measurements... 180

QC statistics... 180 To set up automatic print of built-in QC statistics... 180 Statistical factor...180 To set the statistical factor... 181

Westgard Rules... 181 About Westgard Rules...181 Types of Westgard Rule ...181 Description of the lines used in Westgard rule illustrations... 181 Westgard rules and corrective actions... 181 To set up and enable Westgard Rules... 183 To disable/enable Westgard rules... 183

RiLiBÄK rules... 184 About RiLiBÄK rules...184 To add a new RiLiBÄK rule... 184 To apply all RiLiBÄK rules... 185 To edit a RiLiBÄK rule... 185 To remove a RiLiBÄK rule... 185

Analyzer-specific control ranges... 185 About analyzer-specific control ranges... 185 How to establish analyzer-specific control ranges... 186 Stage 1: To do 20 ampoule-based QC measurements...186 Stage 2: To enable the use of fixed standard deviations... 186 Stage 3: To use the analyzer to change control ranges to analyzer-specific control ranges...187 To manually change control ranges to analyzer-specific control ranges... 188

Maintenance setup... 189 About mandatory and operator-defined activities...189

Mandatory maintenance activities... 189 Other activities... 189 To schedule other activities...189 To set up corrective action for overdue Other activities...190

Operator-defined activities... 190 Operator activities...190 To set up an operator activity... 190 To set up corrective action for pending operator activities... 191 To delete an operator activity...191

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Maintenance planning...191 To plan maintenance activities... 191

Replacement warnings... 191 To set up replacement warnings... 191

Note fields... 192 To create standard texts for use in Note fields... 192 To edit standard texts for use in Note fields... 192 To delete standard texts for use in Note fields... 192

Communications... 192 Data security...192 LIVE Connect...193 To set up a LIS/HIS connection... 193 To set up a AQURE/RADIANCE connection... 194 Patient data from a LIS/HIS or AQURE/RADIANCE system... 194 To set up automatic requests for patient data... 195 To set up automatic transmission of data to a system... 195 To enable manual patient data requests using Patient lookup... 195

Printers... 196 To set up automatic printing... 196 To install an external printer for the analyzer... 196 To edit the name of a printer... 196

Data logs and archives... 196 About data logs and archived data logs... 196 To set up automatic archiving... 197 File format of exported data logs and archived data logs... 197 To export data logs...197 To export data from Archived data logs... 198 To create disc space by exporting and deleting archives... 198 To import archived data logs...198

Data backup and restoration... 199 Backup... 199 Destinations for backup data... 199 To schedule automatic backups... 199 To do a manual backup... 199 To restore data from a backup... 199

Saving and loading setups... 200 To save the setup...200 To load a setup... 200 To restore Radiometer default settings... 200

Radiometer default settings... 201 Operators and profiles - default settings...201 Alarm sound (acoustic signal) settings for events - default settings...202 Language - default setting...202 Analysis setup – default settings... 202 Parameters - default settings... 204 Measurement units - default settings... 205 Calibration schedule - default settings...206 Quality control setups - default settings... 206 Replacement setups - default settings...206 Communication setup - default settings... 207 User-defined patient data items - default settings...207

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Corrective actions – default settings... 208 Miscellaneous setup - default settings... 208 Printer setup - default settings...209 Automatic printing - default settings... 209 Automatic archiving - default settings... 209 Automatic backup - default setting... 209 Setups with no default settings... 209 References... 210

10.

Performance characteristics Measured parameters – definitions... 211

About performance characteristics... 212 Overview of performance characteristics... 212 Uncertainty in performance characteristics... 212 To convert an uncertainty at a 68 % confidence level... 213 Bias... 213 Repeatability and reproducibility... 214 Coefficient of variation (CV %)...214 Confidence intervals... 214 Total analytical error...215

About performance tests...215 Test conditions...215 Reference methods/materials... 216

Performance test results... 217 Rounding rules... 217 pH performance test results... 217 pCO2 performance test results... 218 pO2 performance test results... 219 cK+ performance test results... 220 cNa+ performance test results... 221 cCl– performance test results...222 cCa2+ performance test results... 223 cGlu performance test results... 224 pO2 levels - how they affect cGlu results... 226 cLac performance test results... 227 ctHb performance test results... 228 sO2 performance test results...229 FO2Hb performance test results... 230 FCOHb performance test results...231 FMetHb performance test results...233 FHHb performance test results...234 FHbF performance test results... 235 ctBil performance test results ... 236 ctBil external test results... 237

Interference test results... 239 Interference tests... 239 pH/blood gas...239 Electrolytes... 240 Metabolites... 243 Oximetry parameters...246 ctBil sensitivity for MCHC variations... 254

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Traceability... 256 Traceability to the primary standards at Radiometer...256 pH traceability... 256 pCO2 and pO2 traceability...256 cK+ and cNa+ traceability... 256 cCa2+ traceability... 257 cCl– traceability... 257 cGlu traceability...257 cLac traceability...257 ctHb traceability...257 Saturation – sO2 = 100 % – traceability... 258 Saturation – sO2 = 0 % – traceability... 258 FCOHb – normal value - traceability...258 FCOHb – 100 % - traceability... 258 FMetHb traceability... 258 FHbF traceability... 258 ctBil traceability... 259 References... 259

11.

Derived and input parameters Parameter types... 261 Parameter symbols...261 Input parameters – definitions and acceptable values... 261 Derived parameters...262 Default values of parameters... 263

Definitions of derived parameters... 264 Acid-base derived parameters – definitions...264 Oximetry derived parameters – definitions... 265 Oxygen derived parameters - definitions... 265 Electrolyte derived parameters – definitions...267 Data necessary to derive electrolyte parameters... 267

Calculation of derived parameters... 267 Sample type...267 Units and symbols used in equations... 268

Equations... 268 Equations for acid-base parameters... 268 pH(T) - equation 1... 268 cH+(T) - equation 2...268 pCO2(T) - equation 3... 268 cHCO3–(P) - equation 4...269 cBase(B) - equation 5...269 cBase(B,ox) - equation 6...269 cBase(Ecf) - equation 7... 269 cBase(Ecf,ox) - equation 8... 269 cHCO3–(P,st) - equation 9... 269 ctCO2(P) - equation 10... 270 ctCO2(B) - equation 11... 270 pH(st) - equation 12...270

Equations for electrolyte parameters... 270 Anion Gap, K+ equation 43... 270 Anion Gap - equation 44... 270

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cCa2+(7.4) - equation 45... 270 Equations 46 and 47...271 mOsm - equation 48... 271

Equations for oxygen parameters... 271 pO2(T) - equation 14... 271 pO2(A) - equation 15... 272 pO2(A,T) - equation 16... 272 pO2(a)/FO2(I) - equation 17... 272 pO2(a,T)/ FO2(I) - equation 18... 272 p50 - equation 19... 272 p50(T) - equation 20... 273 p50(st) - equation 21... 273 pO2(A-a) - equation 22... 273 pO2(A-a,T) - equation 23... 274 pO2(a/A) - equation 24... 274 pO2(a/A,T) - equation 25... 274 pO2(x) or px - equation 26... 274 pO2(x,T) - equation 50... 274 ctO2 - equation 27... 275 ctO2(a-v)̄ - equation 28... 275 BO2 - equation 29... 276 ctO2(x) or cx - equation 30... 276 ḊO2 - equation 31... 276 Q̇t - equation 32... 276 V̇O2 - equation 33... 277 FShunt - equation 34...277 FShunt(T) - equation 35... 277 RI - equation 36... 278 RI(T) - equation 37... 278 Qx - equation 38... 279 V(B) - equation 42... 279 VCO2/V(dry air) - equation 51... 279 VO2/V(dry air) - equation 52... 280

Equations for oximetry parameters... 280 FHHb - equation 41... 280 FO2Hb - equation 40...280 sO2 - equation 39...280 Hct - equation 13... 280 FHbF - equation 49... 281 Converting results to other units ... 281

Oxyhemoglobin dissociation curve...282 ODC equations... 282 The ODC reference position... 283 The ODC displacement...283 The actual ODC position...284 To determine the actual displacement... 285 Coordinates on the ODC...286 References... 287

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ABL90 FLEX PLUS: Instructions for use

Principles of operation General construction... 289 Sensors... 289

General measurement principles... 289 Introduction... 289 Activity vs. concentration... 290 Fluid transport system... 290 Measurement process... 291 Rinse process... 292

Calibration... 292 Definition... 292 Frequency...292 Calibration solutions... 292

The calibration equation... 292 About the calibration equation... 292 Plotting a calibration line... 292

Sensitivity, status and drift... 293 Sensitivity...293 Status... 295 Drift... 295

Reference electrode...295 Background information - reference electrode...295 Purpose... 295 Fixed potential...295 Use ... 296

Construction - reference electrode... 296 Construction...296

pH and electrolyte sensors... 296 Construction - pH and electrolyte sensors... 296 Construction...296

Measurement principles - pH and electrolyte sensors... 297 Potentiometric measurement principle... 297 Electrode chain... 297 Electrode chain potential... 298 Derived potential... 298 Ion-sensitive membrane ... 298 Nernst equation... 298 Activity and concentration... 299

Calibration - pH and electrolyte sensors... 299 Calibrations of pH and electrolyte sensors... 299 Calculation of pH and electrolytes sensitivity...299

Measurement - pH and electrolyte sensors... 299 Calculation of pH and electrolyte values... 299 Sensor response stability... 300

pCO2 sensor... 300 Construction - pCO2 sensor... 300 Construction...300

Measurement principle - pCO2 sensor... 301 Electrode chain... 301

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Electrode chain potential... 301 Measurement process in the pCO2 sensor... 301

Calibration - pCO2 sensor...302 Calibrations of the pCO2 sensor ...302 Calibration levels... 302 Calculation of pCO2 sensitivity... 302

Measurement - pCO2 sensor...303 Calculation of pCO2 values... 303 Sensor response stability... 303

pO2 sensor... 303 Measurement principle - pO2 sensor... 303 Optical system for pO2...303 Measurement sequence... 304 Calculations... 304

Calibration - pO2 sensor... 304 Overview of pO2 calibrations...304 Sensitivity...304 Status... 305

Measurement - pO2 sensor...305 Calculation of pO2 values... 305

Glu and Lac sensors... 306 Construction - Glu and Lac sensors... 306 Construction - Glu and Lac sensors...306 Zero current - Glu and Lac sensors... 306

Calibration - Glu and Lac sensors... 307 Calculation of sensitivity – Glu and Lac sensors... 307

Measurement - Glu and Lac sensors... 307 Calculation of Glu and Lac values... 307 Sensor response stability of the glucose and lactate sensors... 307

Measurement principle - Glu and Lac sensors... 308 Amperometric measurement principle for Glu and Lac sensors... 308 Electrode chain – Glu and Lac sensors...308 Measurement process – Glu and Lac... 308

ctHb and derivates... 309 Description of the optical system... 309 Measured parameters... 309 Construction...310 Measurement cycle...310 Lambert-Beer's law... 311 Absorbance... 311 Total absorbance...311 Continuous spectrum...312 Spectrum examples...312 Determining concentrations... 312 Matrix of constants...313

Calibration of the optical system... 313 Calibration materials... 313 Zero point... 313 Cuvette path length...313

Correcting for interferences...314 HbF versus HbA... 314

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Deviation of results... 314 Detecting HbF...314 Correcting for HbF...315 Repressing spectra... 315 Residual spectrum...315

Measurement and corrections... 315 Calculation of the values of the oximetry parameters... 315 Bilirubin...316 Restrictions ... 316 Corrections for ctHb... 317 Corrections for ctBil...317 References... 317

13.

Specifications Analyzer specifications... 319 Ranges of indication and reportable ranges...319 Measurement precision within specified ranges...320 Product specifications... 325 Environmental specifications...327 Power-supply cords... 328

Consumables specifications... 329 Solution Pack... 329 Function of the Solution Pack...329 Solution Pack specifications... 329

Sensor Cassette... 330 Function of the Sensor Cassette... 330 Sensor Cassette specifications... 331

14.

Graphical symbols Explanation of graphical symbols/icons... 333

15.

Ordering information Solution Packs – code numbers... 337 Sensor Cassettes – code numbers... 337 Spare parts and accessories - code numbers...337 Quality control products – code numbers...338 Recommended Radiometer sampling devices - code numbers...338 Power-supply cords - code numbers... 340

16.

Legal information Patents and trademarks... 341 Patents... 341 Trademarks... 341

Legal notices... 341 System performance... 341 Third-party software and trademarks... 341 Warranties and disclaimer... 341

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Confidentiality... 342 Changes... 342 End-user license agreement with Microsoft... 342

Index

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Introduction Intended use

The ABL90 FLEX PLUS analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. The ABL90 FLEX PLUS analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. The ABL90 FLEX PLUS analyzer can be connected to the RADIANCE system. The RADIANCE system enables communication between the RADIANCE server and the ABL90 FLEX PLUS analyzer to allow remote data entry and analyzer access. These tests are only performed under a physician's order. In the table below the measured parameters are shown: Parameter group

Parameter

pH/blood gas:

pH (acidity) pCO2 (carbon dioxide tension) pO2 (oxygen tension)

Oximetry:

ctHb (total hemoglobin concentration) sO2 (oxygen saturation) FO2Hb (fraction of oxyhemoglobin in total hemoglobin) FCOHb (fraction of carboxyhemoglobin in total hemoglobin) FHHb (fraction of deoxyhemoglobin in total hemoglobin) FMetHb (fraction of methemoglobin in total hemoglobin) FHbF (fraction of fetal hemoglobin) ctBil (concentration of total bilirubin in plasma)

Electrolytes:

cK+ (potassium ion concentration) cNa+ (sodium ion concentration) cCa2+ (calcium ion concentration) cCl- (chloride ion concentration)

Metabolites:

cGlu (D-glucose concentration) cLac (L(+)-lactate concentration)

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